Detail

Basic Information Clinical Results Relationship Graph

Basic Information

Gene symbol	STAT3	Synonyms	ADMIO, ADMIO1, APRF, HIES	Type of gene	protein-coding
Chromosome	17	Map location	17q21.2	dbXrefs
Gene perturbation-related omics dataset	PerturbAtlas \| PertOrg
Description	signal transducer and activator of transcription 3

GTO ID	GTC0252
Trial ID	NCT02499328
Disease	Squamous Cell Carcinoma of the Head and Neck
Altered gene	STAT3
Therapeutic/Target gene	Target gene
Therapy	ASO
Treatment	ISIS-STAT3rx\|AZD9150\|ISIS 481464\|IONIS-STAT3-2.5Rx
Co-treatment	MEDI4736
Phase	Phase1\|Phase2
Recruitment status	Active, Not Recruiting
Title	A Phase 1b/2, Open-Label, Multicentre Study Assessing the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of MEDI4736 in Combination With AZD9150 or AZD5069 in Patients With Advanced Solid Malignancies and Subsequently Comparing AZD9150 and AZD5069 Both as Monotherapy and in Combination With MEDI4736 as Second Line Treatment in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck
Year	2015
Country	Belgium\|Germany\|Italy\|Spain\|United Kingdom\|United States
Company sponsor	AstraZeneca
Other ID(s)	D5660C00004\|2015-002525-19

Vector information

Vector	No vector was used

Clinical Result

Cohort1: AZD9150_QW_dose level1_Durvalumab

Administration route	intravenous infusion
Dosage	AZD9150, 2mg/kg, QW\|MEDI4736, 20mg/kg, Q4W
Pts	4
Age	Adult, Older_Adult
Adverse reactions	2/4(All-cause mortality)

Cohort2: AZD9150_QW_dose level2_Durvalumab

Administration route	intravenous infusion
Dosage	AZD9150, 3mg/kg, QW\|MEDI4736, 20mg/kg, Q4W
Pts	7
Age	Adult, Older_Adult
Adverse reactions	3/7(All-cause mortality); 1/7(Gastrointestinal disorders; Respiratory, thoracic and mediastinal disorders)

Cohort3: AZD5069_dose level1_Durvalumab

Administration route	intravenous infusion
Dosage	AZD5069, 40mg, BID\|MEDI4736, 20mg/kg, Q4W
Pts	9
Age	Adult, Older_Adult
Adverse reactions	5/9(All-cause mortality); 3/9(Infections and infestations; Metabolism and nutrition disorders; Respiratory, thoracic and mediastinal disorders)

Cohort4: AZD5069_dose level2_Durvalumab

Administration route	intravenous infusion
Dosage	AZD5069, 80mg, BID\|MEDI4736, 20mg/kg, Q4W
Pts	11
Age	Adult, Older_Adult
Adverse reactions	6/11(All-cause mortality); 5/11(Cardiac disorders; Gastrointestinal disorders; Hepatobiliary disorders; Infections and infestations; Respiratory, thoracic and mediastinal disorders; Vascular disorders)

Cohort5: AZD5069_dose level2_with scheduled dose holds and titrations_Durvalumab

Administration route	intravenous infusion
Dosage	AZD5069, 80mg, BID\|MEDI4736, 20mg/kg, Q4W
Pts	15
Age	Adult, Older_Adult
Adverse reactions	9/15(All-cause mortality); 5/15(Blood and lymphatic system disorder; Cardiac disorders; Gastrointestinal disorders; General disorders; Hepatobiliary disorders; Immune system disorders; Infections and infestations; Respiratory, thoracic and mediastinal disorders)

Cohort6: AZD9150_QW_dose level2_Durvalumab_tremelimumab

Administration route	intravenous infusion
Dosage	AZD9150, 3mg/kg, QW\|MEDI4736, 20mg/kg, Q4W\|tremelimumab, 1 mg/kg, Q4W
Pts	9
Age	Adult, Older_Adult
Adverse reactions	8/9(All-cause mortality); 5/9(Cardiac disorders; General disorders; Infections and infestations; Injury, poisoning and procedural complications; Metabolism and nutrition disorders; Product Issues; Respiratory, thoracic and mediastinal disorders; Vascular disorders)

Cohort7: AZD9150_QW_dose level1_Durvalumab_tremelimumab

Administration route	intravenous infusion
Dosage	AZD9150, 2mg/kg, QW\|MEDI4736, 20mg/kg, Q4W\|tremelimumab, 1 mg/kg, Q4W
Pts	7
Age	Adult, Older_Adult
Adverse reactions	6/7(All-cause mortality); 2/7(Cardiac disorders; Infections and infestations; Metabolism and nutrition disorders; Respiratory, thoracic and mediastinal disorders)

Cohort8: AZD9150_Q2W_dose level2_Durvalumab_tremelimumab

Administration route	intravenous infusion
Dosage	AZD9150, 3mg/kg, Q2W\|MEDI4736, 20mg/kg, Q4W\|tremelimumab, 1 mg/kg, Q4W
Pts	6
Age	Adult, Older_Adult
Adverse reactions	1/6(All-cause mortality); 2/6(Gastrointestinal disorders; General disorders; Hepatobiliary disorders; Musculoskeletal and connective tissue disorders; Psychiatric disorders; Respiratory, thoracic and mediastinal disorders; Vascular disorders)

Cohort9: AZD9150_QW_dose level2_Durvalumab

Administration route	intravenous infusion
Dosage	AZD9150, 3mg/kg, QW\|MEDI4736, 20mg/kg, Q4W
Pts	14
Age	Adult, Older_Adult
Adverse reactions	7/14(All-cause mortality); 3/14(Gastrointestinal disorders; General disorders; Renal and urinary disorders)

Cohort10: AZD9150_QW_dose level2_Durvalumab_expansion

Administration route	intravenous infusion
Dosage	AZD9150, 3mg/kg, QW\|MEDI4736, 20mg/kg, Q4W
Pts	24
Age	Adult, Older_Adult
Adverse reactions	21/24(All-cause mortality); 10/24(Blood and lymphatic system disorders; Endocrine disorders; Gastrointestinal disorders; Infections and infestations; Injury, poisoning and procedural complications; Renal and urinary disorders; Respiratory, thoracic and mediastinal disorders; Vascular disorders)

Cohort11: AZD5069_dose level1_Durvalumab_expansion

Administration route	intravenous infusion
Dosage	AZD5069, 40mg, BID\|MEDI4736, 20mg/kg, Q4W
Pts	20
Age	Adult, Older_Adult
Adverse reactions	18/20(All-cause mortality); 7/20(Cardiac disorders; Gastrointestinal disorders; Infections and infestations; Respiratory, thoracic and mediastinal disorders; Vascular disorders)

Cohort12: AZD9150_QW_dose level2_Durvalumab_Naive

Administration route	intravenous infusion
Dosage	AZD9150, 3mg/kg, QW\|MEDI4736, 20mg/kg, Q4W
Pts	53
Age	Adult, Older_Adult
Adverse reactions	41/53(All-cause mortality); 30/53(Blood and lymphatic system disorders; Cardiac disorders; Endocrine disorders; Eye disorders; Gastrointestinal disorders; General disorders; Hepatobiliary disorders; Infections and infestations; Injury, poisoning and procedural complications; Metabolism and nutrition disorders; Musculoskeletal and connective tissue disorders; Neoplasms benign, malignant and unspecified(incl cysts and polyps); Respiratory, thoracic and mediastinal disorders; Skin and subcutaneous tissue disorders; Vascular disorders)

Cohort13: AZD9150_QW_dose level2_Durvalumab_Naive

Administration route	intravenous infusion
Dosage	AZD5069, 40mg, BID\|MEDI4736, 20mg/kg, Q4W
Pts	22
Age	Adult, Older_Adult
Adverse reactions	16/22(All-cause mortality); 9/22(General disorders; Infections and infestations; Metabolism and nutrition disorders)

Cohort14: AZD9150_QW_dose level2

Administration route	intravenous infusion
Dosage	AZD9150, 3mg/kg, QW
Pts	14
Age	Adult, Older_Adult
Adverse reactions	11/14(All-cause mortality); 9/14(Gastrointestinal disorders; General disorders; Infections and infestations; Metabolism and nutrition disorders; Neoplasms benign, malignant and unspecified(incl cysts and polyps); Nervous system disorders; Renal and urinary disorders; Respiratory, thoracic and mediastinal disorders; Vascular disorders)

Cohort15: AZD5069_dose level2

Administration route	intravenous infusion
Dosage	AZD5069, 40mg, BID
Pts	10
Age	Adult, Older_Adult
Adverse reactions	9/10(All-cause mortality); 6/10(General disorders; Infections and infestations; Injury, poisoning and procedural complications; Nervous system disorders; Respiratory, thoracic and mediastinal disorders)

Cohort16: AZD5069_dose level1_Fed/Fasted

Administration route	intravenous infusion
Dosage	AZD5069, 40mg, BID
Pts	1
Age	Adult, Older_Adult
Adverse reactions	1/1(All-cause mortality); 1/1(Respiratory, thoracic and mediastinal disorders)

Cohort17: AZD5069_dose level1_Fasted/Fed

Administration route	intravenous infusion
Dosage	AZD5069, 40mg, BID
Pts	1
Age	Adult, Older_Adult
Adverse reactions	1/1(All-cause mortality)

Cohort18: AZD9150_QW_dose level2_Durvalumab

Administration route	intravenous infusion
Dosage	AZD9150, 3mg/kg, QW\|MEDI4736, 20mg/kg, Q4W
Pts	55
Age	Adult, Older_Adult
Adverse reactions	35/55(All-cause mortality); 28/55(Blood and lymphatic system disorders; Cardiac disorders; Gastrointestinal disorders; General disorders; Hepatobiliary disorders; Infections and infestations; Injury, poisoning and procedural complications; Neoplasms benign, malignant and unspecified(incl cysts and polyps); Nervous system disorders; Product Issues; Respiratory, thoracic and mediastinal disorders; Vascular disorders)

Cohort19: AZD9150_Q2W_dose level3_Durvalumab

Administration route	intravenous infusion
Dosage	AZD9150, 400mg, q2w\|MEDI4736, 1.5g, Q4W
Pts	22
Age	Adult, Older_Adult
Adverse reactions	22/50(All-cause mortality); 21/50(Blood and lymphatic system disorders; Cardiac disorders; Gastrointestinal disorders; General disorders; Hepatobiliary disorders; Infections and infestations; Metabolism and nutrition disorders; Musculoskeletal and connective tissue disorders; Neoplasms benign, malignant and unspecified(incl cysts and polyps); Nervous system disorders; Psychiatric disorders; Respiratory, thoracic and mediastinal disorders; Vascular disorders)

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